NDAINTRAVENOUSPOWDER
Approved
Jan 2025
Lifecycle
Growth
Competitive Pressure
8/100
Clinical Trials
5
Data completeness
6/8 — Strong
GRAFAPEX (treosulfan) by Medexus Pharmaceuticals is 12. Approved for acute myeloid leukemia, myelodysplastic syndrome. First approved in 2025.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GRAFAPEX (treosulfan) is an intravenous alkylating agent that depletes hematopoietic stem cells while providing immunosuppressive and antitumor activity. It is approved for nine hematologic malignancies and disorders including acute myeloid leukemia, myelodysplastic syndrome, and bone marrow failure syndrome. Treosulfan is a prodrug that converts spontaneously to active epoxide intermediates responsible for DNA alkylation and cytotoxic effects.
Growth3.7 years to LOE
Recent launch in growth phase with nine indications offers significant expansion opportunity; small sponsor size (Medexus) suggests lean but entrepreneurial commercial structure.
Mechanism of Action
12.1 Mechanism of Action Treosulfan is an alkylating agent. DNA alkylation is thought to be responsible for the cytotoxic activities of treosulfan. Treosulfan showed hematopoietic stem cell depleting activity as well as immunosuppressive and antitumor activity in mouse models of leukemia. 12.2…
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.